USPTO Patents Application 08487526

Serial No. 08/487,526
Docket No. 05634.0355

Appendix D

Applicants' Previous Response to
the PTO's Administrative Requirement Filed December 29, 1998

Serial No. 08/487.526
Docket No. 05634.0355

Claim 17 stands rejected under 35 U.S.C. § 103 (a) as being unpatentable over Campbell,
U.S. Pat. No. 4,536,791, in view of Lambert, U.S. Pat No. 4,38l,522,and funher in view of
Nagel, U.S. Pat. No. 4,536,791.

Claims 2-20 remain active in this application. No new matter is presented in the
foregoing amendments. Approval and entry of same is respectfully requested.

B. Response to Requirement Imposed Upon Applicants to Resolve
Alleged Conflicts Between Applicants' Applications.

Applicants note that the requirement of paragraph 8 of the Final Office Action mailed
January 8, 1998, has been essentially reiterated in paragraph 4 of the recent Office Action.
Applicants respectfully maintain the traversal of the requirements of paragraph 4 of the Office
Action and reiterate below the reasons for traversal.

Paragraph 4 of the Office Action requires Applicants to either:

(1) file terminal disclaimers in each of the related 328 applications terminally
disclaiming each of the other 327 applications; or

(2) provide an affidavit attesting to the fact that all claims in the 328 applications
have been reviewed by applicant and that no conflicting claims exist between the applications; or

(3) resolve all conflicts between claims in the related 328 applications by identifying
how all the claims in the instant application are distinct and separate inventions from all the
claims in the above identified 328 applications.

In addition, Examiner states that failure to comply with any one of these requirements
will result in abandonment of the application.

Examiner states that the requirement has been made because conflicts exist between
claims of the related co-pending applications, including the present application. Examiner sets
forth only the serial numbers of the co-pending applications without an indication of which
claims are conflicting. Examiner has also attached an Appendix providing what is deemed to be
clear evidence that conflicting claims exist between the 328 related co-pending applications and
the present application. Further, Examiner states that an analysis of all claims in the 328 related

9

Serial No. 08/487.526
Docket No. 05634.0355

co-pending applications would be an extreme burden on the Office requiring millions of claim
comparisons.

Applicants respectfully traverse these requirements in that Examiner has both improperly
imposed the requirements, and has incorrectly indicated that abandonment will occur upon
failure to comply with the requirement. Applicants' traversal is supported by the fact that 37
C.F.R. § 1.78 (b) does not, under the present circumstances, provide Examiner with authority to
require Applicants to either: 1) file terminal disclaimers; 2) file an affidavit; or 3) resolve all
apparent conflicts. Additionally, the penalty of abandonment of the instant application for failure
to comply with the aforementioned requirement is improper for being outside the legitimate
authority to impose abandonment upon an application. The following remarks in Section (B)
will explain Applicants' basis for this traversal.

1. The E*TO's New Requirement is an Unlawfully
Promulgated Substantive Rule Outside the
Commissioner's Statutory Grant of Power

The PTO Commissioner obtains his statutory rulemaking authority from the Congress
through the provisions of Title 35 of the United States Code. The broadest grant of rulemaking
authority -- 35 U.S.C. § 6 (a) -- permits the Commissioner to promulgate regulations directed
only to "the conduct of proceedings in the [PTO]". This provision does NOT grant the
Commissioner authority to issue substantive rules of patent law. Animal Leeal Defense Fund v.
Quigg, 932 F.2d 920, 930, 18 U.S.P.Q.2d 1677, 1686 (Fed Cir, 1991). ^ Applicants respectfully
submit that the Examiner's creation of a new set of requirements based upon 37 CFR § 1.78(b)
constitutes an unlawful promulgation of a substantive rule in direct contradiction of a long-
established statutory and regulatory scheme.

* Accord Hoechst AktieneesellschaFt v. Ouigg . 917 F.2d 522, 526, 16 U.S.P.Q2d 1549, 1552 (Fed Cir, 1990); Glaxo
Operations UK Ltd. v. Ouigg . 894 F.2d 392, 398-99, !3 U.S.P.Q.Zd 1628, 1632-33 (Fed. Cir. 1990); Ethicon Inc. v.
Ouigg . 849 F.2d 1422, 1425, 7 U.S.P.Q.2d 1 152, 1 154 (Fed. Cir 1988).

10

Serial No. 08/487.526
Docket No. 05634.0355

2. The PTO's Requirement is a Substantive Rule

The first determination is whether the requirement as imposed by the PTO upon
Applicants is substantive or a procedural rule. The Administrative Procedure Act offers general
guidelines under which all administrative agencies must operate. A fundamental premise of
administrative law is that administrative agencies must act solely within their statutory grant of
power. Chevron v. Natural Resources Defense Council, 467 U.S. 837 (1984). The PTO
Commissioner has NOT been granted power to promulgate substantive rules of patent law.
Merck & Co.. Inc. v. Kessler, 80 F.3d 1543 (Fed. Cir. 1996), citing, Animal Legal Defense Fund
^- Quigg. 932 F.2d 920, 930, 18 U.S.P.Q.2d 1677, 1686 (Fed. Cir. 1991).

The appropriate test for such a determination is an assessment of the rule' s impact on the
Applicant's rights and interests under the patent laws. Fressola v. Manbeck, 36 U.S.P.Q.2d
1211, 1215 (D.D.C. 1995). As the PTO Commissioner has no power to promulgate substantive
rules, the Commissioner receives no deference in his interpretation of the statutes and laws that
give rise to the instant requirement. Merck & Co., Inc. v. Kessler, 80 F.3d 1543 (Fed Cir. 1996),
citing, Chevron v. Natural Resources Defense Council, 467 U.S. 837 (1984). When agencv rules
either (a) depart from existing practice or (b) impact the substantive rights and interests of the
effected partv. the rule must be considered substantive . Natl Ass'n of Home Health Agencies v.
Scheiker, 690 F.2d 932, 949 (D.C. Cir. 1982), cert, denied, 459 U.S. 1205 (1983).

a. The PTO Requirement is Substantive Because it
Radically Changes Long Existing Patent Practice
by Creating a New Requirement Upon
Applicants Outside the Scope of 37 C.F.R, § 1.78
(b)

The Examiner's requirement is totally distinguishable from the well articulated
requirement authorized by 37 CFR § 1.78 (b), because it (1) creates and imposes a new
requirement to avoid abandonment of the application based on the allegation that conflicts exist
between claims of the related 328 co-pending applications, and (2) it results in an effective final
double patenting rejection without the PTO's affirmative double patenting rejection of the

11

Serial No. 08/487.526
Docket No. 05634.0355

claims. Long existing patent practice recognizes only two types of double patenting, double
patenting based on 35 U.S.C. § 101 (statutory double patenting) and double patenting analogous
to 35 U.S.C. § 103 (the well-known obviousness type double patenting).- These two well
established types of double patenting use an objective standard to determine when they are
appropriate^ and have a determinable result on the allowability of the pending claims.

The Examiner's new requirement represents a radical departure from long existing patent
practice relevant to conflicting claims between co-pending applications of the same inventive
entity. Two well established double patenting standards are based on an objective analysis of
comparing pending and allowed claims. However, in the present application, there are no
allowed claims. The Examiner's new requirement to avoid a double patenting rejection
presumes that conflicts exist between claims in the present application and claims in the 327
copending applications. This presumption of conflicts between claims represents a radical
departure from long existing patent practice as defined by 37 C.F.R. § 1 .78 (b), which states:

Where two or more applications filed by the same applicant contain conflicting
claims, elimination of such claims from all but one application may be required in
the absence of good and sufficient reason for their retention during pendency in
more than one application.

Clearly, the only requirement authorized by the rule is the elimination of conflicting
claims from all but one application where claims have been determined to exist. Furthermore, in
order to determine that conflicting claims do in fact exist in multiple applications, the only
possible analysis is obviousness-type double patenting, since there are no allowed or issued

-MPEP § 804(B)(1) states, in an admittedly awkward fashion, thai the inquiry for obviousness type double patenting
is analogous to a rejection under 35 U.S.C. 103: "since the analysis employed in an obvious-type double patenting
determination parallels the guidelines for a 35 U.S.C. 103 rejection, the factual inquires set forth in Graham v. John
Deere Co .. 383 U.S. 1, 148 U.S.P.Q. 459 (1966)» that are applied for establishing a background for determining
obviousness under 35 U.S.C. 103 are employed when making an obvious-type double patenting analysis".

^ The objective test for same invention double patenting is whether one of the claims being compared could be
literally infringed without literally infringing the other. The objective test for obviousness type double patenting is
the same as the objective nonobviousness requirement of patentability with the difference that the disclosure of the
first patent may not be used as prior art.

12

Serial No. 08/487,526
Docket No. 05634.0355

claims by which to employ the 35 U.S.C. § 101 statutory double patenting analysis. Once
obviousness-type double patenting analysis has been applied and conflicting claims have been
determined to exist, only a provisional obviousness-type double patenting rejection is possible
until claims from one application are allowed.

In summary, the Examiner's new requirement departs from long-established practice
because it (1) creates and imposes a new requirement to avoid abandonment of the application
based on the allegation that conflicts exist between claims of the related 328 co-pending
applications, and (2) it results in an effective final double patenting rejection without the PTO's
affirmative double patenting rejection of the claims.

Therefore, the Examiner's new requirement departs from existing practice and therefore
is a substantive rule beyond the authority of the PTO and is therefore, invalid.

b- The New Requirement is Also a Substantive Rule
Because it Adversely Impacts the Rights and
Interests of Applicants to Benefits of the Patent

The rights and benefits of a U.S. patent is solely a statutory right. Merck & Co,, Inc, v.
Kessler, 80 F.3d 1543 (Fed Cir. 1996). The essential statutory right in a patent is the right to
exclude others from making, using and selling the claimed invention during the term of the
patent. Courts have recognized that sometimes new procedural rules of the PTO are actually
substantive rules, e.g. when the new rule made a substantive difference in the ability of the
applicant to claim his discovery. Freesola v. Manbeck, 36 U.S.P.Q.2d 1211,1214 (D.D.C. 1995)
(emphasis added), citing, In re Pilkington, 41 1 F.2d 1345, 1349; 162 U.S.P.Q. 145 (C.C.P.A.
1969); diUd In re Steppan, 394F.2d 1013, 1019; 156 U.S.P.Q. 143 (C.C.P.A. 1967).

The new requirement, on its face and as applied here, is an instance of a PTO rule making
a substantive difference in Applicants ability to claim their invention and, therefore, must be
considered a substantive rule. The requirement denies Applicants rights and benefits expressly
conferred by the patent statute. The measure of the value of these denied rights and benefits is
that the requirement, as applied here, would deny Applicants the full and complete PTO

13

Serial No. 08/487.526
Docket No. 05634.0355

examination of Applicants' clainns on their merits, as specified by 37 C.F.R, § 1. 105. In
addition, to file terminal disclaimers in each of the related 328 applications terminally
disclaiming each of the other 327 applications based on the PTO's incomplete examination on
the merits would deny Applicants' the benefit of the full patent term of 17 years on each of
Applicants' respective applications. Applicants respectfully submit that the requirement has a
huge impact on their rights and interests in the presently claimed invention.

c. Conclusion: Substantive Rule

In summary, the requirement is a change to long existing practice and/or has a substantive
impact on the rights and interests of Applicants to their invention. Either finding means that the
new requirement is a substantive rule. Since the Commissioner has no power to issue
substantive rules, the requirement is an improperly promulgated substantive rule having no force
of law.

3. The PTO Requirement is Outside the Scope of 37
C.F.R. § 1.78 (b)

Rule 78 (b) states that:

Where two or more applications filed by the same applicant contain conflicting
claims, elimination of such claims from all but one application may be required in
the absence of good and sufficient reason for their retention during pendency in
more than one application.

The only requirement that Rule 78 (b) authorizes is the elimination of conflicting claims
from all but one co-pending applications.

In the instant Office Action, Examiner has not required the elimination of all conflicting
claims from all but one application, but instead has required Applicants to: 1) file terminal
disclaimers in each of the related 328 applications; 2) provide an affidavit; or 3) resolve all
conflicts between claims in the related 328 applications. None of the options in the requirement
is authorize by Rule 78 (b), and therefore Applicants respectfully submit that such a requirement
is improper.

14

Serial No. 0S/4S7.526
Docket No. 05634.0355

With respect to the PTO's authority to act within Rule 78 (b) regarding the rejection of
conflicting claims, M.P.E.P § 822.01 states that:

Under 37 CFR § 1.78 (b), the practice relative to overlapping clainns in
applications copending before the examiner..., is as follows: Where claims in one
application are unpatentable over claims of another application of the same
inventive entity because they recite the same invention, a complete examination
should be made of the claims of each application and all appropriate rejections
should be entered in each application, including rejections based upon prior art.
The claims of each application may also be rejected on the grounds of provisional
double patenting on the claims of the other application whether or not any claims
avoid the prior art. Where appropriate, the same prior art may be relied upon in
each of the applications. MPEP 822.01 (6th Ed., Rev. 3, 1997), {emphasis added).

In light of the requirement of the Office Action, M.P.E.P § 822.01 and 37 CFR § 1.78

(b) are not applicable since there has not been any rejection with regard to the elimination of

conflicting claims from all but one co-pending application,

4. The Assertion That Failure to Comply with the
Requirement Will Result in Abandonment of
Applicants' Application is Improper

Applicants' prospective failure to comply with the above requirements cannot properly

result in abandonment of the present application. Applicants respectfully submit that

abandonment of an application can properiy occur only:

(1) for failure to respond within a provided time period (under Rule 135);

(2) as an express abandonment (under Rule 138); or

(3) the result of failing to timely pay the issue fee (under Rule 3 1 6).

There is no provision in the rules permitting abandonment for failure to comply with any
of the presented requirements. To impose an improper requirement upon Applicants and then
hold the application is to be abandoned for failure to comply with the improper requirement
violates the rules of practice before the USPTO. Furthermore, Examiner is in effect attempting
to create a substantive rule which is above and beyond the rulemaking authority of the USPTO,
and therefore is invalid.

15

Serial No. 08/487,526
Docket No. 05634.0355

In the Application ofMott, 539 F.2d 1291, 190 USPQ 536 (CCPA 1976), the applicant
had conflicting claims in multiple applications. The CCPA held that action by Examiner which
would result in automatic abandonment of the application was legally untenable. Id, at 1296, 190
USPQ at 541. In the present application, Examiner has asserted that there are conflicting claims
in multiple applications, and that non-compliance of the Office Action's requirement will result
in an automatic abandonment. Therefore, under Mott's analysis, the Office Action's result of
abandonment of Applicant's application is legally untenable.

5. Response to Apparent Conflict of Claims

Applicants submit that the presentation of the Office Action Appendix fails to
demonstrate any conflicts between claims of the present application and claims of the co-pending
applications. Rather, the Office Action Appendix compares representative claims of other
applications in attempt to establish that "conflicting claims exist between the 328 related co-
pending applications." Absent any evidence of conflicting claims between the Applicants'
present application and any other of Applicants' co-pending applications, any requirement
imposed upon Applicants to resolve such alleged conflicts is improper.

6. Request for Withdrawal of Requirement

Therefore, Applicants respectfully request that Examiner reconsider and withdraw the
requirement that Applicants: (1) file terminal disclaimers in each of the related 328 applications
terminally disclaiming each of the other 327 applications; (2) provide an affidavit attesting to the
fact that all claims in the 328 applications have been reviewed by applicant and that no
conflicting claims exist between the applications; or (3) resolve all conflicts between claims in
the above identified 328 applications by identifying how all the claims in the instant application
are distinct and separate inventions from all the claims in the above' identified 328 applications,
which upon failing to do so will abandon the application.

16

Serial No. 08/4S7.526
Docket No. 05634.0355

7. Filing of Supplemental Oath

Notwithstanding the foregoing, Applicants will file a supplemental oath under 37 C.F.R.
§ 1.67 for each application when Examiner identifies allowable subject matter. Applicants
respectfully propose that the filing of individual supplemental oaths attesting to the absence of
claim conflicts between previously patented claims and subsequently allowed claims is a more
reasonable method of ensuring the patentable distinctness of subsequently allowed claims.

Under 37 C.F.R. § 1.105, § 1.106 &§ 1.78 (b). Examiner has the duty to make every
applicable rejection, including double patenting rejection. Failure to make every proper rejection
denies Applicants all rights and benefits related thereto, e.g.. Applicants' right to appeal, etc.
Once obviousness-type double patenting analysis has been applied and conflicting claims have
been determined to exist, only a provisional obviousness-type double patenting rejection is
possible until claims from one application are allowed.

C- Response to Rejections under 35 U.S.C. § 112

1. Rejections Under 35 U.S.C- §112, Second Paragraph

Claims 2-8 are rejected under 35 U.S.C. §112, second paragraph, as being indefinite for
failing to particularly point out and distinctly claim the subject matter which the Applicants
regard as the invention. It is noted that the phrase **said at least two or more specific portions" in
claim 2 lacked sufficient antecedent basis. Claim 2 has been amended to positively set forth *'at
least two or more specific portions."

2. Conclusion

Applicants respectfully submit that claims 2-8 particularly point out and claim the subject
matter sufficiently for one of ordinary skill in the art to comprehend the bounds of the claimed
invention. The test for definiteness of a claim is whether one skilled in the art would understand
the bounds of the patent claim when read in light of the specification, and if the claims so read
reasonably apprise those skilled in the art of the scope of the invention, no more is required.
Credle v. Bond, 25 R3d 1556, 30 U.S.P.Q.2d 191 1 (Fed. Cir. 1994). The legal standard for

17